FREQUENT QUESTIONS: FOOD AND DRUG ADMINISTRATION

 

FDA REGULATIONS FOR FOOD AND BEVERAGES

 

What is the FDA and what does it imply?

 

The FDA is the agency of the US government. Responsible for food regulation (both humans and animals), medicines (human and veterinary), cosmetics, medical devices (human and animal), biological products and blood derivatives. For food regulation, the FDA controls the labels of foodstuffs to ensure that their information is true and protect the consumer.


 The FDA regulates:

 

• Food, except most meat and poultry products, which are regulated by the US Department of Agriculture.

• Food Additives

• Child formulas

• Dietary supplements

• Medicines for human use

• Vaccines, other biological and blood products

• Medical devices

• Electronics products that emit radiation (eg microwave)

• Food, medicines and devices for pets

 

The FDA is responsible for:

Protect public health by regulating human and veterinary medicines, vaccines and other biological products, medical devices, food supplies in our country, cosmetics, dietary supplements and products that emit radiation.

• Promote public health through the promotion of product innovations.

• Provide the public with the necessary, accurate, science-based information that allows them to use drugs and food to improve their health.

• Inspect manufacturers, suppliers, facilities, and laboratories that house products that will be sold in the US. To verify that the regulation of said administration is fulfilled.

Since June 2002, US law requires mandatory compliance with the Bioterrorism Act for any exporter to the US. For this the following requirements must be met:

1. Registration of agri-food facilities that produce, pack, process food, beverages or pharmaceutical products intended for human or animal consumption.

2. Need for resident agent.

 

What is the resident agent?

 

With regard to the agent, any company that registers with the FDA, must have an Agent designated for the purposes of the Act, regardless of whether the company may have other commercial agents. The Agent is a physical and legal person, as defined in the Food, Drug and Cosmetics Act, who must reside or maintain a US business, and be physically in the country. Its mission is to act as the only communication link between the establishment and the FDA. The FDA will contact you in both routine and emergency situations.

3. Prior notice of shipment of goods for all shipments of goods to the US, advising with minimum time of what is intended to be introduced in the country.

 

What is the Prior Notice?

 

As of December 12, 2003, the FDA must be informed in advance of any shipments of food to humans and other animals imported into the United States, unless the food is excluded from the prior notice. Prior notice of imported food shipments will give the FDA time to:

• Review and evaluate information before a food product arrives in the US.

• Better deployment of resources to carry out inspections

• Helping to intercept contaminated products

4. File of all documentation related to shipments.

5. Compulsory registration of Sanitary Incidents.

 

HOW CAN WE HELP FROM THE CAMERA TO YOUR BUSINESS?

 

1. We help you with registration of incorporation and transfer of FDA account.

2. We offer basic export and discount advice on a basic listing of importers.

3. Ability to create trade agendas or sectoral notes at a discount.

4. We will be the resident agent before the FDA - natural or legal person with availability to attend any FDA request and transmit it to the company in question.

5. We can help you with the revision of the labeling of your products. Any product that enters the US Must have a labeling in accordance with the FDA regulations that include, among others, manufacturers, weight, nutritional tables, allergens and any other relevant information.

6. We process your import permit for alcoholic beverages with the TTB.

 

These are just some of the benefits of E-Member or FDA Members from $ 250 annually
($ 450 for a 2 year registration)


What is the profile of the e-members partner?


They are usually SMEs in the agri-food sector, usually located in Spain, who export their products to the North American market to a local importer or distributor. In order to be able to export their products they need the figure of the Chamber of Commerce as a resident agent before the FDA (Food and Drug Administration).

For more information contact FDA@spainchamber.org or visit our Membership section.